Status:
TERMINATED
A Triple-targeted Cell Preparation Targeting CD19/CD20/CD22 in Patients With Relapsed/Refractory B-cell Acute Lymphocytic Leukemia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
Nanjing Legend Biotech Co.
Conditions:
Acute Lymphocytic Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LCAR-AIO, a triple-targeted cell preparation targeting CD19/CD20/CD22, in patients with relapsed/refractory B...
Detailed Description
This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of LCAR-AIO in patients ≥ 18 years of age with relapsed or refractory B-cell acute lymphocytic l...
Eligibility Criteria
Inclusion
- Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent;
- Age 18-75 years;
- ECOG score: 0-1;
- Detect the expression of at least one of CD19/CD20/CD22 in leukemic cells by Flow cytometry in peripheral blood or bone marrow
- Leukemia cells in the bone marrow \>5%
- Pathologically confirmed relapsed/refractory ALL must meet one of the following conditions:
- Naive patients who failed to achieve CR1 after standard chemotherapy;
- relapse within 12 months after CR1, or relapse after 12 months but fail to achieve CR2
- twice or more bone marrow relapse
- Philadelphia chromosomal positive (Ph+) and unable to tolerate TKI therapy, failed TKI therapy more than 2 lines, or had contraindications for TKI therapy
- Clinical laboratory values meet screening visit criteria
- Expected survival ≥ 3 months;
Exclusion
- Prior antitumor therapy with insufficient washout period; 2.CNS infiltration; Except for patients with prior CNS infiltration who are currently in remission; 3.Have received two or more targets (CD19/CD20/CD22) CAR-T cell therapy (including but not limited to sequential infusion) at any previous time, or have received CAR-T cell therapy from Camel family origin; 4.With acute or chronic graft-versus-host disease; 5.Isolated extramedullary relapse, but hepatic, spleen, or lymph node-isolated extramedullary relapse is acceptable; 6.HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive; 7.Pregnant or lactating women;
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Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05292898
Start Date
March 14 2022
End Date
March 31 2025
Last Update
June 3 2025
Active Locations (2)
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1
Beijing Gobroad BoRen Hospital
Beijing, Beijing Municipality, China
2
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China